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Trial Title:
Testing and Evaluating the Collection of Patient Reported Outcomes In Cancer Care Using Innovative Approaches
NCT ID:
NCT05911672
Condition:
Cancer
Conditions: Keywords:
cancer
digital health
Ecologically Momentary Assessment
Ecologically Momentary Intervention
Virtual Reality
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
patients will be randomized into three groups: Full Intervention; Partial Intervention
and Control
Primary purpose:
Supportive Care
Masking:
Double (Participant, Care Provider)
Masking description:
Patients and providers (nurses and clinicians) will be blinded on the type of
intervention received.
Intervention:
Intervention type:
Device
Intervention name:
PRICE
Description:
Working closely with 51 cancer patients, medical and paramedical personnel, we
co-designed an intelligent personalized mobile application to first collect ecologically
momentary assessment data on symptoms like pain and fatigue and Health-Related Quality of
Life and subsequently enhance symptom management of cancer patients at home. The full
description is available here:
https://dl.acm.org/doi/abs/10.1145/3491101.3503562?casa_token=tC5fSN8-k5EAAAAA:56_TMf6Hit
VQXZypY2j9FCCcroIFZW9kxxzCEt0yJNFJmNrv79m9W7htznSzMWqGLwE4eimBU0vkLA
Arm group label:
Full Intervention
Arm group label:
Partial Intervention
Summary:
Patient Reported Outcome Measures (PROMs) are patients' reports of their symptom
experience, quality of life and functionality. These measures are used as an endpoint to
clinical trials but rarely integrated into routine cancer care. Moreover, they are
resource intensive and prone to retrospective biases. PRICE project aims to develop and
evaluate a digital health tool (ePROM), collecting PROMs at the clinic and additional
Ecological Momentary Assessment (EMA) of PROMs using a mobile application. In addition it
tests whether patients who are identified to have elevated pain, fatigue, and stress will
benefit from an Ecological Momentary Intervention (EMI) based on Virtual Reality
environments. EMA can overcome biases and barriers in PROM assessment whilst EMI can
offer an easy and possibly cost-effective intervention until patients re-visit the
clinic. The project can contribute to monitoring patient data and achieve viable health
systems. It is also timely since digital health tools are considered the future of
oncology care but often lack robustness in development and evaluation. Patients treated
for cancer at the German Oncology Centre in Cyprus will be randomized into three
conditions: (a) Full Intervention (patients who are prompted to use the EMI based on
their EMA data; (b) Partial Intervention (patients who are prompted to use the EMI
irrespective of their EMA data); (c) Control (patients who only provide their EMA without
an EMI). A dissemination strategy will ensure findings and innovation are available to
the public, clinicians, students and policy-makers.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Diagnosed with any type of cancer
- Treated as either inpatient or outpatient
- Good understanding of Greek
- Able to consent
- No psychiatric comorbidities
Exclusion Criteria:
- Diagnosed with psychiatric disorders
- Unable to consent
Gender:
All
Minimum age:
18 Years
Maximum age:
100 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cyprus University of Technology
Address:
City:
Limassol
Country:
Cyprus
Contact:
Last name:
Angelos Kassianos, PhD
Phone:
0035725002252
Phone ext:
2252
Email:
angelos.kassianos@cut.ac.cy
Contact backup:
Last name:
Andri Georgiou, MSc
Email:
antri_geor3@hotmail.com
Start date:
June 20, 2023
Completion date:
June 20, 2024
Lead sponsor:
Agency:
Cyprus University of Technology
Agency class:
Other
Collaborator:
Agency:
German Oncology Center, Cyprus
Agency class:
Other
Collaborator:
Agency:
CYENS Centre of Excellence
Agency class:
Other
Source:
Cyprus University of Technology
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05911672
